The following data is part of a premarket notification filed by Innocoll Pharmaceuticals with the FDA for Collieva.
Device ID | K081782 |
510k Number | K081782 |
Device Name: | COLLIEVA |
Classification | Dressing, Wound, Collagen |
Applicant | INNOCOLL PHARMACEUTICALS DUBLIN ROAD Athlone, Co. Westmeath, IE |
Contact | Aaron Wyse |
Correspondent | Aaron Wyse INNOCOLL PHARMACEUTICALS DUBLIN ROAD Athlone, Co. Westmeath, IE |
Product Code | KGN |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-06-23 |
Decision Date | 2008-09-30 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() COLLIEVA 77306733 3525403 Dead/Cancelled |
Bourne Capital Partners, LLC 2007-10-17 |